About Apotex Inc.
Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, cutting-edge branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.
For more information visit: www.apotex.com.
Job Summary
Exective is responsible for overseeing all process optimisation, Trail & validation activities in compliance with GMP, SOPs, and global regulatory guidelines (Health Canada, FDA, EU). The role includes supervision, training, and development of personnel involved in execution and protocol & report preparation, with accountability for work scheduling, project prioritization, and timely resolution of roadblocks.Job Responsibilities
Site technology Transfer:

Prepare, review,



and update standard operating procedures and Validation Master Plan.
Coordinate and review quality risk management (QRM).
Prepare and review cleaning validation protocols and reports. Perform cleaning validation product risk assessments to identify worst-case molecules for cleaning validation.
Cleaning validation related activities and e-Residue software application activities.
Prepare and review PDE changes.
Prepare and review of quarterly and annual monitoring reports for cleaning validation.
Prepare for regulatory audits and ensure compliance.
Prepare and review Annual Product Quality Review (APQR) and data trending for products (3B).
Review and approve process validation protocols and reports for demonstration, optimization, qualification, and verification batches.
Prepare and review process validation and APQR activities in QMS Track wise.
Conduct QA assessments for change control, ac

📌 Executive - Manufacturing, Science & Technology (NOS) (India)
🏢 Apotex
📍 India